510(k) · Cleared
ClearedNaviject SUB2-1P, Model: LP604430
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicel AG · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Jul 28, 2009 as substantially equivalent to K070669 (Medicel AG, 2007) after a 22-day review. Its family tree reaches back 4 generations to 1994. 18 later devices descend from it.
- Decided
- Jul 28, 2009
- Review
- 22 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930320 (1994). 6 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 3 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 2 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 1 generation backK070669 Iol Injector SetMedicel AG · 2007 · Recalled
- This deviceK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- Descendant · cites it directly · 12 of its ownK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK131958 Bausch & Lomb Injector SystemBausch & Lomb · 2014
- Descendant · cites it directly · 7 of its ownK103495 Asico Softip Injector SystemAsico, LLC · 2011
- Descendant · 2 generations on · 6 of its ownK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK172228 pioli IOL Delivery SystemAst Products, Inc. · 2017
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012 · cites it directly12descendants
- K131958Bausch & Lomb Injector SystemBausch & Lomb · 2014 · 2 generations on9descendants
- K103495Asico Softip Injector SystemAsico, LLC · 2011 · cites it directly7descendants
- K142056Lioli Iol Delivery SystemAst Products, Inc. · 2015 · 2 generations on6descendants
- K172228pioli IOL Delivery SystemAst Products, Inc. · 2017 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −3 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −2 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −1 | K070669 | Iol Injector Set | Medicel AG | 2007 | 1 |
| 0 (this device) | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| +1 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
| +2 | K131958 | Bausch & Lomb Injector System | Bausch & Lomb | 2014 | — |
| +1 | K103495 | Asico Softip Injector System | Asico, LLC | 2011 | — |
| +2 | K142056 | Lioli Iol Delivery System | Ast Products, Inc. | 2015 | — |
| +3 | K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSS device
- #1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070669 | Iol Injector SetSummary page 1…TM Device Trade Name: Naviject Sub2-1IP IOL Injector Set Equivalent legally-marketed devices: K070669, IOL Intraocular Injector Set, Medicel AG Section 1I1 Medicel AG… | 2007 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K113852 (Bausch & Lomb, Inc., 2012) has gone furthest, with 12 descendants of its own.
How does its category compare?
All MSS devicesMSS Folders And Injectors, Intraocular Lens (Iol): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MSS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSS
54in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSS
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSS
429in 2025
MAUDE reports naming product code MSS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 445 |
| 2008 | 5 | 84 | 0 | 185 |
| 2009 | 5 | 197 | 0 | 186 |
| 2010 | 2 | — | 0 | 203 |
| 2011 | 2 | — | 0 | 95 |
| 2012 | 2 | — | 0 | 129 |
| 2013 | 5 | 141 | 0 | 203 |
| 2014 | 5 | 78 | 0 | 114 |
| 2015 | 3 | 156 | 0 | 127 |
| 2016 | 2 | — | 1 | 112 |
| 2017 | 3 | 30 | 1 | 114 |
| 2018 | 1 | — | 0 | 340 |
| 2019 | 3 | 67 | 0 | 271 |
| 2020 | 2 | — | 0 | 362 |
| 2021 | 1 | — | 0 | 289 |
| 2022 | 0 | — | 0 | 490 |
| 2023 | 3 | 54 | 0 | 330 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 1 | — | 0 | 429 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Naviject Sub2-1 P IOL Injector and Cartridge Set for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092023: Naviject SUB2-1P, Model: LP604430.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092023
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026